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A Trial of the Efficacy and Safety Trial of ABY-035 in the Treatment and Prevention of Relapse/Recurrence of Non-anterior Uveitis (LINNAEA)

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ClinicalTrials.gov Identifier: NCT04706741
Recruitment Status : Not yet recruiting
First Posted : January 13, 2021
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
Affibody

Tracking Information
First Submitted Date  ICMJE January 11, 2021
First Posted Date  ICMJE January 13, 2021
Last Update Posted Date January 19, 2021
Estimated Study Start Date  ICMJE April 2021
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2021)
Time to Treatment Failure [ Time Frame: Week 10 to Week 50 ]
Treatment Failure" is defined as Yes/No by visit by meeting at least 1 of the following criteria in at least one eye:
  1. Inflammatory, chorioretinal and/or inflammatory retinal vascular lesions - New active, inflammatory lesions relative to BL
  2. ACC Count - Inability to achieve ≤ 0.5+ (Week 10) or 2-step increase relative to best state achieved (<Week 10)
  3. Vitreous Haze - Inability to achieve ≤ 0.5+ (Week 10) or 2-step increase relative to best state achieved (<Week 10)
  4. Visualt acuity - Worsening of BCVA by ≥ 15 letters relative to best state achieved (not due to cataract)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of the Efficacy and Safety Trial of ABY-035 in the Treatment and Prevention of Relapse/Recurrence of Non-anterior Uveitis
Official Title  ICMJE A Phase 2 Trial of the Efficacy and Safety of the Interleukin-17A Inhibitor ABY-035 in the Treatment and Prevention of Relapse/Recurrence of Non-infectious Intermediate, Posterior or Pan-uveitis, Including an Initial Pilot Phase
Brief Summary This is a multinational, multicenter, phase 2 proof-of-concept trial to explore the efficacy and safety of ABY-035 in treating and preventing relapse/recurrence of disease activity in patients with non-Infectious Intermediate, Posterior, Pan-Uveitis with significant BL disease activity despite treatment with stable doses of corticosteroids (≥7 to ≤40 mg/day oral prednisolon or equivalent).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The primary purpose of the study is prevention of relapse/recurrence of Noninfectious Intermediate, Posterior or Pan-uveitis

The trial consist of two parts, a pilot part - Part A - and Part B

Part A includes one treatment arm (Arm-0)

Part B is planned to include 3 treatment arms - to which the subjects will be randomized

Masking: None (Open Label)
Masking Description:
Part A will be open-label. Part B (arm-2 and arm-3) will be masked with regards to ABY-035/Placebo
Primary Purpose: Treatment
Condition  ICMJE Uveitis
Intervention  ICMJE
  • Drug: ABY-035
    ABY-035 is an Interleukin-17 Inhibitor that will be administered subcutaneously
  • Drug: Prednisolone/Prednisone
    Background Corticosteroid
  • Drug: Placebo
    Placebo to ABY-035
Study Arms  ICMJE
  • Experimental: ABY-035 and maintenance corticosteroid dose
    ABY-035 + Prednisolon/Prednisone
    Interventions:
    • Drug: ABY-035
    • Drug: Prednisolone/Prednisone
  • Experimental: ABY-035 and corticosteroid burst
    ABY-035 + Prednisolon/Prednisone
    Interventions:
    • Drug: ABY-035
    • Drug: Prednisolone/Prednisone
  • Placebo Comparator: Placebo and corticosteroid burst
    Placebo + Prednisolon/Prednisone
    Interventions:
    • Drug: Prednisolone/Prednisone
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 11, 2021)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. ≥18 years of age at SCR
  2. Previously documented medical history with diagnosed unilateral or bilateral NIIPPU
  3. Active disease at BL defined by the presence of at least 1 of the following criteria in at least one eye despite treatment with stable doses of corticosteroids for at least 2 weeks:

    1. Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion by Dilated Indirect Ophthalmoscopy (DIO) and Fundus Photography to determine whether a lesion is active or inactive (the central reader's assessment using Fundus Photography is required to confirm eligibility).
    2. ≥2+ vitreous haze ( NEI/SUN criteria) by DIO and Fundus Photography (the central reader's assessment using Fundus Photography is required to confirm eligibility).
  4. On treatment with oral corticosteroids (≥7 to ≤40 mg/day oral prednisolon or equivalent) at a stable dose for at least 2 weeks before BL

Exclusion Criteria:

  1. Subject with isolated anterior uveitis
  2. Subject with Occlusive Behçet's disease, Acute Posterior Multifocal Placoid Pigment Epitheliopathy, Acute Posterior Pigment Epithelitis, Multiple Evanescent White Dot Syndrome, Punctate Inner Choroiditis or serpiginous choroidopathy
  3. Subject with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, syphilis, cytomegalovirus, Lyme disease, toxoplasmosis, Human T-Lymphotropic Virus Type 1 infection, Whipple's disease, herpes zoster virus, and herpes simplex virus
  4. Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial
  5. Planned (elective) eye surgery within 80 weeks after BL
  6. History of prior refractive laser surgery, retinal laser photocoagulation, or neodymium-doped yttrium aluminium garnet posterior capsulotomy within 30 days before BL
  7. History of any other prior ocular surgery within 90 days before BL
  8. Subject with intraocular pressure (IOP) of ≥25 mmHg while on ≥2 glaucoma medications or evidence of glaucomatous optic nerve injury
  9. Subject with severe vitreous haze that precludes visualization of the fundus at BL
  10. Subject has a contraindication for mydriatic eye drops OR subject cannot be dilatated sufficiently well to permit good fundus visualization
  11. Subject with BCVA <20 letters (ETDRS) in at least one eye at BL
  12. Subject with intermediate uveitis or panuveitis who has presence or history of whitish exudates on the inferior pars plana (snowbanking) or vitreal inflammatory aggregates (snowballs) in combination with a medical history or signs or symptoms suggestive of a demyelinating disease such as multiple sclerosis
  13. Subject with proliferative or severe non-proliferative diabetic retinopathy or clinically significant macular edema due to diabetic retinopathy
  14. Subject with neovascular/wet age-related macular degeneration
  15. Subject with an abnormality of the vitreo-retinal interface (i.e., vitreomacular traction, epiretinal membranes, etc.) with the potential for macular structural damage independent of the inflammatory process
  16. Subject with a history of active scleritis within 12 months of SCR Criteria that relate to comorbidity
  17. Uncontrolled inflammatory bowel disease
  18. Infection requiring treatment with IV anti-infectives within 30 days before BL or oral anti-infectives within 14 days before BL
  19. Subject with any active infection that based on the investigator's clinical assessment makes the subject an unsuitable candidate for the trial
  20. History or any signs of lymphoproliferative disease, or a known malignancy or a history of malignancy within the previous 3 years (except for basal cell or squamous cell carcinoma of the skin that had been fully excised with no evidence of recurrence) Criteria that relate to laboratory testing
  21. A positive test for subclinical/latent TB infection (i.e. positive QuantiFERON®-TB Gold test or equivalent product) suggestive of TB at SCR will require that the subject is thoroughly evaluated for active tuberculosis. If the subject is diagnosed with latent TB and active TB can be ruled out, the subject can be included if the subject has gone through an adequate course of prophylaxis as per local standard of care 12 weeks prior to SCR.
  22. Positive Fluorescent treponemal (FTA)- absorption test (syphilis)
  23. Subject with intolerance to high-dose oral corticosteroids (equivalent to oral prednisolon 1 mg/kg/day or 60 mg/day)
  24. The subject has received any biologic therapy (including ABY-035 or any other IL-17i or IL-17 receptor inhibitor, e.g. secukinumab, ixekizumab, brodalumab or anti-TNF-alpha therapy) within 8 weeks before BL.
  25. Subject on >1 concomitant non-biologic NCSIT
  26. Subject on 1 concomitant non-biologic NCSIT:

    a) But the medication is not listed as permissible b) The medication is listed as permissible, but the dose has not been stable within the last 3 months before BL c) The medication is listed as permissible, but the dose exceeds the allowable level; to be acceptable, the dose needs to be: i) Methotrexate (MTX) ≤25 mg/week ii) CsA ≤4 mg/kg/day iii) Mycophenolate mofetil ≤2 grams/day or an equivalent drug to mycophenolate mofetil (e.g., mycophenolic acid) at an equivalent dose approved by the Medical monitor iv) Azathioprine ≤175 mg/day v) Tacrolimus (oral formulation) ≤8 mg/day

28] The subject has received Retisert®, Iluvien®, or Yutiq® (glucocorticosteroids implant) within 3 years before BL or who has had complications related to the device. The subject has had any of these glucocorticosteroids implant (glucocorticosteroid implant) removed within 90 days before BL or has had complications related to the removal of the device 29] The subject has received intraocular or periocular corticosteroids within 90 days before BL 30] The subject has received Ozurdex® (dexamethasone implant) within 6 months before BL 31] The subject has received intravitreal methotrexate within 90 days before BL 32] The subject has received intravitreal anti- Vascular Endothelial Growth Factor (VEGF) therapy:

  1. within 45 days of BL for Lucentis® (ranibizumab) or Avastin® (bevacizumab)
  2. or within 60 days of BL for anti-VEGF Trap (aflibercept)
  3. or within 84 days of BL for Beovu® (brolucizumab) 33] Subject on systemic carbonic anhydrase inhibitor within 1 week before SCR 34] Subject on cyclophosphamide within 30 days before BL 35] Prior or current use of chlorambucil
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Karin Grünbaum +46730718201 linnaea@affibody.se
Contact: Per Dalen, MD, PhD linnaea@affibody.se
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04706741
Other Study ID Numbers  ICMJE ABY-035-203
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Affibody
Study Sponsor  ICMJE Affibody
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Affibody
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP